SA4503 8-Week Study in Major Depressive Disorder (MDD)

A Phase II, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety and Efficacy of Treatment With SA4503, Once Daily for 8 Weeks, in Subjects With Major Depressive Disorder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00551109

Enrollment

150

Registered

2007-10-30

Start date

2007-11-30

Completion date

2008-09-30

Last updated

2008-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Brief summary

The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD.

Detailed description

Further study details as provided by M's Science Corporation:

Interventions

DRUGplacebo

placebo, oral administration, once daily for 8 weeks

DRUGSA4503 Low

Low dose, oral administration, once daily for 8 weeks

DRUGSA4503 High

High dose, oral administration, once daily for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female between the ages of 18 and 65 (inclusive) * Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria and a shortened MINI evaluation * HAM-D17 score of \>/= 21 and a severity score of at least 2 for Item 1 (depressed mood) at both Screening and Baseline * Current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to Screening.

Exclusion criteria

* Subjects who have received fluoxetine within 1 month prior to Baseline or any other antidepressant within 2 weeks prior to Baseline, or any unlicensed medication within 1 month before Screening * Subjects who require psychotropic medication other than the study medication * Subjects who started psychotherapy within 4 months prior to Screening * Subjects who currently (i.e., in the month prior to Screening) meet DSM-IV criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders * Subjects who have a primary diagnosis of anxiety * Subjects who regularly use sleeping medication more than 3 times per week * Subjects who have major psychiatric or neurologic disorders other than MDD * Subjects with depression secondary to stroke, cancer, or other severe medical illness * Subjects who have a history of alcohol or substance dependence(within 1 year prior to Screening)

Design outcomes

Primary

Measure	Time frame
Montgomery-Åsberg Depression Rating Scale (MADRS)	8 weeks

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026